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NCT00964457 Clinical Trial

Treatment of Patients With Advanced Rectum Cancer With Capecitabine and Oxaliplatin Before, Under and After Radiation and With Adding Cetuximab to K-RAS Wild-type Patients

Rectum Cancer Clinical Trial

Official title:
Treatment of Patient With Advanced Rectum Cancer With Capecitabine and Oxaliplatin Before Under and After Radiation and With Adding Cetuximab to K_RAS Wild-type Patients.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00964457
Other study ID # GI0905
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received August 21, 2009
Last updated August 24, 2009
Start date August 2009
Est. completion date July 2017

Study information
Verified date August 2009
Source Copenhagen University Hospital at Herlev
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial Summary

response rate to adding cetuximab, oxaliplatin and capecitabine to radiation for advanced rectum cancer

Description:

Dynamic MRI will be used to monitor the effect of the treatment and will be compared to pathologic results.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date July 2017
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- advanced rectum cancer

Exclusion Criteria:

- prior radiation

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• cetuximab
cetuximab 500mg per meter square every second week

Locations
Country Name City State
Denmark Herlev Hospital Herlev

Sponsors (1)
Lead Sponsor Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary response rate 3 years No
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